Edesa Biotech Reports Additional Positive Results from Phase 3 Paridiprubart Study

Core Insights - Edesa Biotech, Inc. announced positive results from a Phase 3 study of paridiprubart, demonstrating a significant reduction in 28-day mortality across a broad patient population [1][2][3] Study Results - The study involved 278 patients, including 104 requiring invasive mechanical ventilation (IMV) and 174 non-IMV patients, showing a 27% relative reduction in mortality from 33% to 24% (p<0.001) [2][3] - In a subgroup of 174 non-IMV patients, paridiprubart reduced mortality from 23% to 15%, a 35% relative reduction (p<0.05) [4] - Exploratory analyses indicated consistent mortality reductions in patients with serious comorbidities, with overall adverse events being low and similar between treatment groups [5] Patent and Regulatory Developments - Edesa has filed provisional patent applications for paridiprubart's use in treating sepsis, acute kidney injury, and pneumonia, with core patents extending into the 2030s [6] - The company is advancing regulatory discussions and exploring strategic collaborations to accelerate development and broaden access [8] Future Studies and Presentations - Paridiprubart is being evaluated in a separate U.S. government-funded study with enrollment ongoing for approximately 200 subjects [9] - Edesa has been selected for an oral presentation at the ATS 2026 conference to share additional findings from the Phase 3 study [12] Mechanism and Background - Paridiprubart is a first-in-class anti-TLR4 antibody designed to modulate the immune response in various critical conditions, including ARDS, which has high mortality rates and limited treatment options [19][20] - ARDS accounts for 10% of ICU admissions globally, representing over 3 million patients annually [20] Company Overview - Edesa Biotech focuses on developing innovative treatments for inflammatory and immune-related diseases, with a clinical pipeline that includes both medical dermatology and respiratory therapeutic areas [21]